A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
TORL Biotherapeutics, LLC
Study ID
NCT06005740
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TORL-4-500 — DRUG
    antibody drug conjugate

Study Details

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).

Key Dates

Start date
Dec 4, 2023
Status verified
Oct 2024
Primary completion
Oct 31, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Dose Dose Finding - Part 1
    TORL-4-500 iv once every 3 weeks
  • Experimental: Expansion as Monotherapy - Part 2
    TORL-4-500 iv once every 3 weeks

Primary Outcome Measure

Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Mayo Clinic PhoenixPhoenixArizona85054
Mohamad Sonbol, MD
Mohamad Sonbol, MD (PRINCIPAL_INVESTIGATOR)
Providence Medical FoundationFullertonCalifornia92835
Yung Lyou, MD
UCLA - JCCC Clinical Research UnitLos AngelesCalifornia90095
Lee Rosen, MD
310-829-5471
Torrance Memorial Physician NetworkTorranceCalifornia90505
Justin Tiulim, MD
Justin Tiulim, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Yanyan Lou, MD
Yanyan Lou, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists Lake Nona Drug Development UnitOrlandoFlorida32827
Cesar Perez, MD
Cesar Perez, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Andrea Wahner-Hendrickson, MD
Andrea Wahner-Hendrickson, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsLexingtonVirginia22031
Alexander Spira, MD

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Mayo Clinic Phoenix· Phoenix, AZProvidence Medical Foundation· Fullerton, CAUCLA - JCCC Clinical Research Unit· Los Angeles, CATorrance Memorial Physician Network· Torrance, CAMayo Clinic Jacksonville· Jacksonville, FLFlorida Cancer Specialists Lake Nona Drug Development Unit· Orlando, FL

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